Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies (PESAPRO)

October 14, 2016 updated by: Dra.Cristina Martinez Payo

The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. The investigators propose a clinical trial with the objective to identify effective strategies to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.

The investigators intend to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to apply, and they present very few maternal-fetal secondary effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. Since 1990, many published articles describe the sonographic measurement of the cervix from the week 16 as method of population screening to detect women at risk. Several studies provide evidence about an inverse relationship between the cervical length and the risk of preterm delivery. For this reason, if there is an effective intervention for patients with cervix short (about < 25mm), made this measure in the middle of the second term, the investigators could reduce the prematurity. Regarding possible therapeutic strategies, recent published data demonstrate the effective of vaginal progesterone and cervical pessary in this population. However, both treatments have never been compared and none of the two strategies are indicated in this population. Therefore it results necessary to compare both treatments in order to establish clinical recommendations. The investigators propose a clinical trial to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries in order to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • University Hospital Quiron Dexeus
      • Burgos, Spain, 09006
        • Burgos University Hospital
      • Ciudad Real, Spain, 13005
        • Ciudad Real General University Hospital
      • Guadalajara, Spain, 19002
        • Guadalajara General University Hospital
      • León, Spain, 24071
        • University Hospital de León
      • Madrid, Spain, 28023
        • Sanitas La Zarzuela Hospital
      • Madrid, Spain, 28046
        • University Hospital Ramón y Cajal
      • Madrid, Spain, 28050
        • Sanitas La Moraleja Hospital
      • Málaga, Spain, 29004
        • University Hospital Quirón Málaga
      • Valladolid, Spain, 47012
        • University Hospital Rio Hortega
      • Valladolid, Spain, 47005
        • Valladolid Clinic Universitary Hospital
      • Zaragoza, Spain, 50009
        • University Hospital Miguel Servet
    • Alicante
      • Sant Joan d'Alacant, Alicante, Spain, 03550
        • University Hospital San Juan de Alicante
    • Barcelona
      • Igualada, Barcelona, Spain, 08700
        • Igualada Hospital
    • Madrid
      • Alcalá de Henarés, Madrid, Spain, 28805
        • University Hospital Príncipe de Asturias
      • Alcorcón, Madrid, Spain, 28922
        • University Hospital Fundación de Alcorcón
      • Boadilla del Monte, Madrid, Spain, 28660
        • University Hospital Madrid Monte Principe
      • Fuenlabrada, Madrid, Spain, 28942
        • University Hospital Fuenlabrada
      • Getafe, Madrid, Spain, 28905
        • University Hospital de Getafe
      • Leganés, Madrid, Spain, 28911
        • University Hospital Severo Ochoa
      • Majadahonda, Madrid, Spain, 28222
        • University Hospital Puerta de Hierro
      • Mostoles, Madrid, Spain, 28933
        • University Hospital Rey Juan Carlos I
      • Móstoles, Madrid, Spain, 28935
        • University Hospital Mostoles
      • San Sebastián de los Reyes, Madrid, Spain, 28702
        • Hospital Infanta Sofía
      • Valdemoro, Madrid, Spain, 28040
        • Hospital Infanta Elena
    • Palamos
      • Gerona, Palamos, Spain, 17320
        • Palamos Hospital
    • San Sebastian
      • Donostia, San Sebastian, Spain, 20080
        • Hospital Universitario DE Donostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women with short cervix (=< 25 mm) identified by use of routine transvaginal ultrasonography at 19-22 weeks of gestation.
  • Single pregnancy
  • Women older than 18 year-old
  • Women sign informed consent according GCP and local legislation
  • Gestational age at randomization between 20+1 and 23+6 weeks.

Exclusion Criteria:

  • Major fetal abnormalities
  • Major uterine abnormalities
  • Placenta praevia during current pregnancy
  • Vaginal bleeding or ruptured membranes in the moment of randomization
  • Cervical cerclage in situ
  • History of cone biopsy
  • Allergic to peanuts
  • Contraindication for Progesterone usage.
  • Active treatment with Progesterone at randomization.
  • History of 3 or more premature labor.
  • If in the investigator's opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psycho-social that could negatively influence.
  • Women unable to give the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal micronized progesterone
200 mg vaginal route per day
Drug: Vaginal micronized progesterone
200 mg vaginal route per day
Active Comparator: Cervical pessary
Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)
Device: Cervical pessary
Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of spontaneous preterm birth before 34 weeks of gestation
Time Frame: up to 11 weeks (from date of randomization until delivery)
up to 11 weeks (from date of randomization until delivery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of spontaneous preterm birth before 37 weeks of gestation
Time Frame: up to 17 weeks (from date of randomization until delivery)
up to 17 weeks (from date of randomization until delivery)
Proportion of Spontaneous preterm birth before 28 weeks of gestation
Time Frame: up to 8 weeks (from date of randomization until delivery)
up to 8 weeks (from date of randomization until delivery)
Rate of premature rupture of membranes before 34 weeks of gestation
Time Frame: up to 11 weeks (from date of randomization until delivery)
up to 11 weeks (from date of randomization until delivery)
Weight at birth
Time Frame: up to 21 weeks (from date of randomization until delivery)
up to 21 weeks (from date of randomization until delivery)
Rate of fetal and neonatal mortality
Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks
From date of randomization until the date of delivery, assessed up 21 weeks
Symptomatic vaginal infections during treatment period
Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks
From date of randomization until the date of delivery, assessed up 21 weeks
Proportion of participants with adverse events
Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks
From date of randomization until the date of delivery, assessed up 21 weeks
Rate of Chorioamnionitis during third term
Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks
From date of randomization until the date of delivery, assessed up 21 weeks
Need of admission because of premature labor before 34 weeks of gestation
Time Frame: up to 14 weeks (from date of randomization until delivery)
up to 14 weeks (from date of randomization until delivery)
Rate of neonatal morbidity
Time Frame: From date of randomization until the date of delivery, assessed up 21 weeks
From date of randomization until the date of delivery, assessed up 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dra.Cristina Martinez Payo

Investigators

  • Principal Investigator: Sara Cruz Melguizo, Dr, University Hospital Puerta de Hierro Majadahonda
  • Principal Investigator: Cristina Martinez Payo, Dr., University Hospital Puerta de Hierro Majadahonda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PESAPRO-2012
  • 2012-000241-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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